DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets— 510(k) K221919

Substantially Equivalent

Hemodia Sas

FDA 510(k) clearance K221919 for DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets, Substantially Equivalent on 2023-03-09. Applicant: Hemodia Sas.

Clearance details

Applicant: Hemodia Sas
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2022-07-01
Decision date: 2023-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Labege, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.